Effects of Assistive Device on ADL Function in Patients With Nerve Injury
NCT ID: NCT05302141
Last Updated: 2023-04-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
31 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-03-21
Study Completion Date
2022-09-20
Brief Summary
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Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
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Detailed Description
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Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries.
Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Keywords: Neural injury, 3D printing, assistive device, hand function.
Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.
Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Keywords: Neural injury, 3D printing, assistive device, hand function.
Conditions
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Nerve Injury
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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3D printing assistive device group
experimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week).
Group Type
EXPERIMENTAL
Wear 3D printing assistive device
Intervention Type
BEHAVIORAL
Wear 3D printing aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
universal cuff groups
control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week).
Group Type
ACTIVE_COMPARATOR
Wear universal cuff device
Intervention Type
BEHAVIORAL
Wear universal cuff aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
Interventions
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Wear 3D printing assistive device
Wear 3D printing aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
Intervention Type
BEHAVIORAL
Wear universal cuff device
Wear universal cuff aids and engage in functional tasks, including eating, typing, and writing.
At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
* Able to understand wearing operation instructions and have the ability to give informed consent
* Able to control shoulder lifting and bending elbows, but difficult to grasp tools
* Able to understand wearing operation instructions and have the ability to give informed consent
* Able to control shoulder lifting and bending elbows, but difficult to grasp tools
Exclusion Criteria
* Older than 75 years old and younger than 20 years old
* Severe visual or hearing impairment
* Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
* Severe visual or hearing impairment
* Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
Minimum Eligible Age
20 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sponsor GmbH
OTHER
Sponsor Role
collaborator
Taipei Medical University Shuang Ho Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hsinchieh Lee, master
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University Shuang Ho Hospital
Locations
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Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
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N202201010
Identifier Type: -
Identifier Source: org_study_id
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